Ondansetron Kalceks

Medicinal product

(Invented) name

Ondansetron Kalceks

Active substance (s)

Ondansetronas

Strength

2 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A04AA01, Ondansetron

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2021-10-01

Date of renewal

Documents

4815 Pakuotės lapelis 2024 10 01.docx

4815 Ondansetron Kalceks PL 2024 10 01, VRA rastas 17041.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0215/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Ondansetronas	2 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
107278	93382	1093382	ampulė	2 ml N5		Receptinis	LT/1/21/4815/001	Netiekiama	-	-	No	-	-
107279	93383	1093383	ampulė	2 ml N10		Receptinis	LT/1/21/4815/002	Netiekiama	-	-	No	-	-
107280	93384	1093384	ampulė	2 ml N25		Receptinis	LT/1/21/4815/003	Netiekiama	-	-	No	-	-
107281	93385	1093385	ampulė	4 ml N5		Receptinis	LT/1/21/4815/004	Netiekiama	-	-	No	-	-
107282	93386	1093386	ampulė	4 ml N10		Receptinis	LT/1/21/4815/005	Tiekiama	-	-	No	-	-
107283	93387	1093387	ampulė	4 ml N25		Receptinis	LT/1/21/4815/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-01	Registruotas